Assumption of Sylimarin, Pyrroloquinoline, Quinone Sodium Salt and Myricetin: Effects on Alcohol Levels and Markers of Oxidative Stress
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in nitrite and nitrate (NO2 and NO3) concentration
研究概览
简要总结
Alcohol abuse is one of the most common causes of mortality worldwide, also associated with increased oxidative stress and end-organ damage in chronic assumption.
This study intend to evaluate the effect of the intake of a product contain silymarin, pyrroloquinoline quinone sodium salt, and myricetin (conventionally for this project Si.Pi.Mi.) on alcohol, ethyl glucuronide (EtG) and markers of oxidative stress levels on regular wine assumption over a predefined time period.
详细描述
The included subjects,will be randomized in a controlled, single-blinded trial to evaluate the intake of a product containing silymarin, pyrroloquinoline quinone sodium salt, and myricetin (conventionally for this project Si.Pi.Mi.) on alcohol levels and markers of oxidative stress.
Inclusion criteria:
- age between 18 and 35 years;
- no history of alcohol abuse or other substances.
- Caucasian ethnicity.
- no smoker;
- good health condition, no autoimmune, endocrine, infectious, cardiac, renal, hepatic or metabolic diseases;
- no pregnancy or lactation condition. Subjects will be asked to avoid the use of aspirin, paracetamol, or other anti-inflammatory drugs in the 7 days before and during the experiment and the assumption of caffeine in the 12 hours before the test. Furthermore, volunteers will be asked to avoid any alcoholic intake in the 7 days before and during the experiment except the one intended for the experiment.
All subjects will sign a consent after receiving proper information about the risks and benefits of this study.
Anthropometric data (height, weight, age) will be tracked at the beginning. Venous blood samples will be drawn for standardized clinical hematological analyses such as: mean cell volume (MCV), hepatic function including aspartate transferase (AST), alanine transferase (ALT), γ-glutamyltransferase (γ GT), total and fractionated bilirubin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
same taste, same case, just a letter on the external case.
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age between 18 and 35 years;
- •no history of alcohol abuse or other substances.
- •Caucasian ethnicity.
- •no smoker;
- •good health condition, no autoimmune, endocrine, infectious, cardiac, renal, hepatic or metabolic diseases;
- •no pregnancy or lactation condition.
排除标准
- •pregnancy
- •age falling outside limits
- •any disease
结局指标
主要结局
Change in nitrite and nitrate (NO2 and NO3) concentration
时间窗: Day 1 and 7: at 0 and 240 min after drinking 150 mL of red wine + SiPiMi or placebo.
nitrite and nitrate (NO2 and NO3) concentration on urine (by colorimetry based on the Griess reaction (μM)
Change in Total Antioxidant Capacity
时间窗: Blood and Saliva: Day 0 (baseline); Day 1 and 7: 60, 120 and 240 min after drinking 150 mL of red wine + SiPiMi or placebo. On saliva alone: Day 2, Day 3, Day 4, Day 5, Day 6, in the morning.
Total antioxidant capacity on blood and saliva (by paramagnetic resonance) (mM)
Change in lipid peroxidation markers
时间窗: Day 1 and 7: at 0 and 240 min after drinking 150 mL of red wine + SiPiMi or placebo.
Lipid peroxidation assessed by measuring 8-isoprostane and 8-OH deoxyguanosine concentration (by competitive immunoassay) (pg mg-1 creatinine)
Change in Blood Alcohol Levels
时间窗: Day 1 and 7: 60, 120 and 240 min after drinking 150 mL of red wine + SiPiMi or placebo.
Measurement of blood alcohol levels (g/L) (by isothermal elution)
Change in Reactive oxygen species production
时间窗: Blood and Saliva: Day 0 (baseline); Day 1 and 7: 60, 120 and 240 min after drinking 150 mL of red wine + SiPiMi or placebo. On saliva alone: Day 2, Day 3, Day 4, Day 5, Day 6, in the morning.
Reactive oxygen species production on blood and saliva (μmol/min) (by paramagnetic resonance)
Change in Co Q10 coenzyme levels
时间窗: Day 1 and 7: at 0 and 240 min after drinking 150 mL of red wine + SiPiMi or placebo.
CoQ10 levels on blood (by competitive inhibition enzyme immunoassay) (μg/mL)
Change in aminothiols levels
时间窗: Day 1 and 7: 0, 60, 120 and 240 min after drinking 150 mL of red wine + SiPiMi or placebo.
total (tot) and reduced (red) aminothiols on blood (by fluorescence spectroscopy) (μmol L-1)
Change in Renal damage markers
时间窗: Day 1 and 7: at 0 and 240 min after drinking 150 mL of red wine + SiPiMi or placebo.
Renal damage by measuring on urine: creatinine (g-L-1), neopterin (μmol·mol-1 creatinine), and uric acid levels (mg/dl), (by isocratic high-pressure liquid chromatography)
Change in Urine Ethyl Glucuronoide
时间窗: Day 1 and 7: at 0 and 240 min after drinking 150 mL of red wine + SiPiMi or placebo.
Urine Ethyl Glucuronoide measurement on urine (ng/mL) (by enzymatic immunoassay)
次要结局
未报告次要终点
研究者
Gerardo Bosco
Associate Professor
University of Padova